DESOWEN desonide 0.5 mg/g lotion bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

desonide, Quantity: 0.5 mg/g

Available from:

Galderma Australia Pty Ltd

INN (International Name):

Desonide

Pharmaceutical form:

Lotion

Composition:

Excipient Ingredients: light liquid paraffin; propylene glycol; sorbitan monostearate; stearyl alcohol; sodium lauryl sulfate; self-emulsifying glyceryl monostearate; cetyl alcohol; methyl hydroxybenzoate; edetate sodium; propyl hydroxybenzoate; sodium hydroxide; citric acid; purified water

Administration route:

Topical

Units in package:

60 mL bottle, 100 mL bottle, 30 mL bottle, 10 mL bottle

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Desowen Lotion 0.05% is indicated for the relief of inflammatory and pruritic manifestations of corticosteroid responsive dermatoses for adults and children aged 2 years and older.

Product summary:

Visual Identification: White to off-white, soft, smooth lotion; Container Type: Bottle; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

1998-12-21

Patient Information leaflet

DESOWEN LOTION _(0.5mg/g desonide) _
1
DESOWEN LOTION
_0.5 mg/g desonide _
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about DESOWEN lotion.
It does not contain all the available
information.
It does not take the place of talking
to your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking DESOWEN
lotion against the benefits this
medicine is expected to have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE. You may need to read it
again.
WHAT DESOWEN LOTION
IS USED FOR
DESOWEN lotion is used for the
treatment of the redness, swelling
and itching that is associated with a
number of skin ailments such as
eczema and psoriasis.
It
acts
by
constricting
the
blood
vessels of the skin and affects the
release of natural chemicals which
cause redness and swelling.
It belongs to a group of medicines
called corticosteroids.
Your doctor, however, may have
prescribed DESOWEN lotion for
another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY DESOWEN
lotion HAS BEEN PRESCRIBED FOR
YOU.
There is no evidence that
DESOWEN lotion is addictive.
DESOWEN lotion is available only
with a doctor's prescription.
BEFORE YOU USE
DESOWEN LOTION
_WHEN YOU MUST NOT USE IT_
DO NOT USE DESOWEN LOTION IF:
1. YOU HAVE EVER HAD AN ALLERGIC
REACTION TO :

MEDICINES CONTAINING
_DESONIDE_

ANY OF THE INGREDIENTS LISTED
AT THE END OF THIS LEAFLET
2. YOU HAVE SKIN AREAS AFFECTED
BY VIRAL SKIN INFECTIONS (SUCH
AS COLD SORES, SHINGLES OR
CHICKEN POX)
3. YOU HAVE SKIN AREAS AFFECTED
BY FUNGAL OR PARASITIC SKIN
INFECTIONS (SUCH AS THRUSH,
TINEA OR RINGWORM)
4. YOU HAVE ACNE OR ROSACEA
UNLESS YOUR DOCTOR TELLS YOU
TO
5. YOU HAVE SKIN AREAS WITH
ULCEROUS WOUNDS
6. YOU ARE GOING TO HAVE A BATH,
SHOWER OR ARE GOING
SWIMMING. IF YOU DO YOU MAY
REDUCE THE EFFECTIVENESS OF
THIS PRODUCT.
IF YOU ARE NOT SURE WHETHER YOU
SHOULD BE USING DESOWEN
LOTION, TALK TO

Summary of Product characteristics

Desowen PI 1
AUSTRALIAN PRODUCT INFORMATION
DESOWEN
_Desonide 0.05% _
1
NAME OF THE MEDICINE
Desonide
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each g of DESOWEN lotion, ointment and cream contains 0.5 mg of
desonide.
Desonide is a nonfluorinated corticosteroid. Desonide is a white
powder or crystal. Practically insoluble
in water; sparingly soluble in alcohol and in acetone; soluble in
chloroform.
For the full list of excipients, see section 6.1 LIST OF EXCIPIENTS.
DESOWEN Lotion: contains: hydroxybenzoates
DESOWEN Cream: contains sorbates
3 PHARMACEUTICAL FORM
DESOWEN lotion is a white to off-white, soft, smooth lotion.
DESOWEN ointment is a smooth, soft, translucent, grease-like ointment.
DESOWEN cream is a white, shiny, semi-solid emulsion.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Desowen Cream 0.05%, Lotion 0.05% and Ointment 0.05% is indicated for
the relief of inflammatory
and pruritic manifestations of corticosteroid responsive dermatoses
for adults and children aged
2 years and older.
4.2 DOSE AND METHOD OF ADMINISTRATION
Desowen (desonide) Cream 0.05%, Lotion 0.05% or Ointment 0.05% should
be applied as a thin film
to the affected areas two to three times daily depending on the
severity of the condition. Shake lotion
well before using.
Occlusive dressing may be used for the management of psoriasis or
recalcitrant conditions. If an
infection develops the use of occlusive dressings should be
discontinued and appropriate antimicrobial
therapy instituted.
Periods of continuous treatment should not exceed 8 weeks in adults or
children.
An increase in the number of daily applications may exacerbate the
adverse effects without enhancing
the therapeutic effects.
Treatment of large skin areas requires monitoring of the number of
tubes used.
4.3 CONTRAINDICATIONS
Topical corticosteroids are contraindicated in those patients with a
history of hypersensitivity to any of
the components of the preparations.
DESOWEN preparations are also contraindicated in most viral infections
of the skin (vaccinia, herpes